About this episode

Kelly Stone discusses the evolution and role of the U.S. Food and Drug Administration in drug approval and safety.

Join us as Kelly Stone, MD, PhD, FAAAAI, explains the evolution of the U.S. Food and Drug Administration and its central role in ensuring the safety and efficacy of therapeutics in the United States. We discuss the modern drug approval process from preclinical development through clinical trials and post-marketing surveillance and explore what makes this pathway different for biologics and biosimilars so you have a better understanding of the therapeutics that we prescribe every day in ...

People in this episode

Guest: Kelly Stone, MD, PhD, FAAAAI

Topics covered

• FDA
• drug approval process
• therapeutics
• biologics
• biosimilars
• clinical trials

Keywords

• FDA
• drug approval
• therapeutics
• biologics
• biosimilars
• clinical trials
• safety
• efficacy

Mentioned in this episode

Organizations: U.S. Food and Drug Administration

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